Landmark legislation designed to alert consumers to where their drugs were made is headed for a full Senate vote, but safety experts say the transparency bill has been stripped of two of its most critical provisions.<\/p>\n
The Clear Labels Act was introduced earlier this year<\/a> by Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., after lawmakers and drug safety experts called for more transparency in the industry. Last year, a ProPublica investigation revealed that the U.S. kept importing generic drugs from foreign factories after inspectors had identified quality and safety lapses at the sites, including leaks, mold and contaminated water<\/a>.<\/p>\n Medications made at these facilities were linked to thousands of reported adverse reactions in patients.<\/p>\n The bill aims to allow doctors and patients to see on the label exactly where a medication was made \u2014 details that had largely been withheld until now, even from Congress. Current generic drug labels often include only the location of the packager or distributor, which can be thousands of miles away from the actual manufacturer.\u00a0<\/p>\n One provision made the law particularly strong, experts said: The label was supposed to include a unique code that the Food and Drug Administration uses to identify factories. That code would have made it easier for researchers and the public to track the regulatory histories of specific facilities.\u00a0<\/p>\n The requirements also were supposed to take effect as early as a year after the bill\u2019s passage.<\/p>\n Senators have now struck both of those provisions. People familiar with the deliberations said lawmakers worried the requirements would raise drug prices and weaken national security by revealing the precise locations where lifesaving medications are made.\u00a0<\/p>\n The unique identifier requirement has been removed from the bill, and the timeline for companies to come into compliance was extended to five years.<\/p>\n \u201cIt\u2019s just a clear watering down of the original bill,\u201d said retired Army Col. Vic Suarez, a former medical supply-chain commander who has been leading a push for more domestic pharmaceutical manufacturing.\u00a0<\/p>\n He and others also questioned why drug companies need multiple years to comply.<\/p>\n \u201cFive years after it passes might as well be a lifetime,\u201d said Dr. Kevin Schulman, a professor of medicine and health policy at Stanford University who has researched the economic pressures<\/a> that lead to poor-quality generic drugs. \u201cWhy is it that the supply chain, the medical distributors and the retailers don\u2019t want to make sure that they supply the highest-quality product?\u201d<\/p>\n In a joint press release, Scott and Gillibrand praised the bill\u2019s progress in the Senate, calling it a \u201cmassive win for consumer safety and transparency,\u201d but did not address the changes.<\/p>\n A representative from Gillibrand\u2019s office said the five-year delay is meant to give the FDA time for rulemaking, which is a complicated, often yearslong<\/a> process used to introduce new regulations. The delay would also give manufacturers time to come into compliance and redesign their labels, the representative said.<\/p>\n But Peter Baker, a former FDA inspector whose work involved the very companies impacted by the bill, said that amount of time is unnecessary.\u00a0<\/p>\n \u201cIf they wanted to do it in one year, they could,\u201d Baker said. \u201cI would love to hear their justification on why they need five years to develop some rules and guidance on transparency. \u2026 I mean, it\u2019s a simple label change.\u201d<\/p>\n The new version of the legislation also removes the key requirement to include a unique facility identification number on labels, called a DUNS number, which would have allowed the public to more easily trace a generic drug and its active ingredients to the factories where they were made. In some cases, that identifier could also be used to find FDA inspection reports that describe contamination and other safety breakdowns on factory floors.<\/p>\n ProPublica used that ID number to collect data for Rx Inspector<\/a>, a first-of-its-kind tool that allows consumers and doctors to look up where more than 40,000 generic drugs are made. Pharmacists and patients are already using the tool to learn more about the drugs they take and prescribe<\/a>.<\/p>\n Under the bill\u2019s updated language, drug labels will only be required to include factory addresses, which can be inconsistent and hard to trace to a manufacturing facility. A single address in India, for example, can house multiple factories, each producing its own drugs, or each with a slight variation on the same address.\u00a0<\/p>\n ProPublica reporters ran into this issue when collecting data for the Rx Inspector tool. In 69% of prescription drug labels, reporters found a generic drug manufacturer\u2019s DUNS number and were able to directly connect it to a specific facility. However, when only a manufacturer\u2019s address was available, linking a drug to a particular facility became much harder, requiring a complicated process of automated address verification, geolocation and extensive manual review.<\/p>\n Experts also worried about certain language in the legislation that could allow manufacturers to avoid identifying where their factories are at all. Representatives for the bill\u2019s sponsors have said that manufacturers are required to identify the factory where drugs were made, but the legislation only mentions a \u201cplace of business.\u201d Drugmakers could potentially list the address for their headquarters or a subsidiary location in the United States rather than a factory overseas.<\/p>\n \u201cIf, in fact, \u2018place of business\u2019 can be interpreted as the location of the importer or the headquarters or something like that, it would be no different than what we have today,\u201d said Ohio State University professor John Gray, who testified before the Senate Special Committee on Aging, led by Scott and Gillibrand.<\/p>\n \u201cThen we\u2019ll be right back to where we are,\u201d Gray said. \u201cIt\u2019ll say \u2018Manufactured for So-and-So in New York City,\u2019 but it\u2019s actually made somewhere else around the world.\u201d<\/p>\n \u201cPaper Trail\u201d Podcast<\/p>\n Learn more about this story on ProPublica\u2019s podcast \u201cPaper Trail.\u201d<\/p>\n People familiar with negotiations over the bill\u2019s language said they are confident that manufacturers won\u2019t have a loophole. The changes to the bill were primarily made as a compromise between committee offices and stakeholders, they said, and the FDA will have final say in what counts as an acceptable address.<\/p>\n The Association for Accessible Medicines, the generic drug lobbying group, did not respond to multiple requests for comment. A spokesperson for the association previously spoke out against the bill to ProPublica, saying the additional requirements would cause \u201csignificant costs in exchange for limited return.\u201d<\/p>\n The lobbying group spent over $1 million<\/a> between January and July on healthcare and generics-related bills, including the Clear Labels Act, according to its public filings.\u00a0<\/p>\n